Signs Of Improving FDA Inspection Outcomes At Indian Sites But Long Road Ahead
Moving up the manufacturing compliance curve is still a work in progress for several Indian firms, but there appear to be some early signs that US FDA inspection outcomes, in general, may have improved.
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The two-day India Pharmaceutical Forum in Mumbai highlighted key aspects of quality management and its challenges, trends on inspection outcomes in India and emerging concerns of 'dangerous cross contamination.'
Sudarshan Jain, the new secretary general of the Indian Pharmaceutical Alliance and ex-Abbott managing director, wears many hats, including that of a senior advisor with a private equity advisory firm. He recounts having “survived in different cultures” in his career and outlines the priorities in his new role, amid continuing questions around generic quality.
Public health experts tell committee that much work lies ahead in strengthening the regulatory systems of low-and middle-income countries, and recommend ways to bolster these systems and improve the quality of imports.